Business Analyst – RD and QC EnvironmentAkkodis is an organization with more than 1,000 engineering, scientific and digital experts in Belgium. Our mission is clear: create a smarter future together! We are a one-stop-shop for engineering, IT, Life Science, and new technologies. Our combined passion for talent and technology allows us to look at the world differently.With our 360° offer we support companies in all sectors in implementing Smart Industry solutions, from the up and reskilling of entire teams to the delivery of complete projects. Our added value? We make incredible happen!What do you do all day?As a Business Analyst, you will act as the link between business needs, technical solutions, and regulatory requirements related to Computer System Validation. You will ensure that systems and solutions comply with quality standards and industry regulations. You will oversee small and medium-sized projects design and implementation, ensuring that business needs are well defined, and development have followed QA and data integrity guidance.This position covered scope is the QC and RD environment of a global biopharmaceutical company and, therefore, includes best practices sharing with GQC and other RD centers. It's a hybrid position that will allow you to combine work at home and on customer site.You are also an integral part of an Akkodis platform, within our customer teams, which means you'll have daily follow-up and support from people who know your work environment. In addition, you will also be encouraged to propose initiatives to diversify the activities of this platform and improve its functioning. Just as, depending on your availability and level of expertise, you could provide support to other Akkodis platforms.Your responsibilities:As Business analyst, you are in charge to:o Analyze the business needs: Collaborate with operational teams to gather, analyze, and document their requirements for data simplification and reduction.o Convert business requirements into clear and understandable functional specifications for technical teams.o Work closely with project managers and internal/external stakeholders to contribute to project management.o Identify areas for improvement in existing processes to enhance the efficiency and performance of data analysis.o Ensure IT systems comply with regulatory requirements (GxP, FDA 21 CFR Part 11, Eudralex Annex 11, etc.).o Participate in risk assessments and define validation strategies tailored to each system.o Train end-users on newly deployed tools and solutions and support them in their adoption.o Help the team to draft and implement validation documents such as Validation Plans (VP), User Requirements Specifications/Functional Requirements Specifications (URS/FRS), test scripts (IQ/OQ/PQ), and final reports, when necessary.o Maintain accurate and up-to-date documentation related to system validation.o Stay up to date with the latest standards and technologies related to the management and validation of IT systems in the pharmaceutical field.o Participate to the administrative tasks of the team (complete follow-up files, continuous improvement, etc.) and weekly follow-up meetings.Your profile:o You have excellent analytical and synthesis skills to interpret complex data and propose appropriate solutions.o You have knowledges of data management tools (advanced Excel, Power BI, SQL or equivalent).o You are familiar with GxP standards, FDA 21 CFR Part 11, and/or EU Annex 11 guidelines.o You have experience or high affinity with computer/software area.o You master the Microsoft Office software.o You are proficiency in French and English, both written and spoken.o You know how to handle pressure situations, and you could respond resiliently to an emergency event.o You have strong interpersonal skills, excellent communication abilities, team spirit, and the ability to work in a dynamic, multidisciplinary environment.o You are organized, proactive, solution-oriented, open-minded, and flexible.o Which can be seen as a plus:• You have proven experience in Computer System Validation (CSV) in a GxP context.• You have experience in Pharmaceutical Manufacturing, RD or Quality Control Environment.• You are familiar with the use of laboratory softwares and/or equipments.• You have already performed URS, IQ/OQ and/or PQ for equipment qualification.• You have scientific background, with knowledge in laboratory analysis technics, like cell biology, immunology, biochemistry and/or microbiology.• You already have experience using SAP and/or Documentum/Veeva.What’s the offer you can’t refuse?As an AKKODIS Team member, you will be:o Onboarded in your position via a buddy process and supported in your career by your Business Manager.o Actor of your training plan and your personal and professional development.o Benefit from a full time permanent AKKODIS contract with competitive salary package including several extra-legal benefits.o In a nice work environment atmosphere within an international group.o Invited to attractive events calendar including afterwork, life sciences meeting, and other professional gatherings.